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External Focus of Attention Feedback to Reduce Risk of Non-contact ACL Injury

Primary Purpose

Anterior Cruciate Ligament Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Internal focus of attention feedback
Visual internal focus of attention feedback
Auditory external focus of attention feedback
Sponsored by
University of North Carolina, Charlotte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anterior Cruciate Ligament Injuries

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • exercise 30+ minutes 3+ days/week

Exclusion Criteria:

  • Body mass index >40 kg/m2
  • History of lower extremity fracture or surgery to either limb
  • History of ACL tear, meniscus, or collateral ligament injury at the knee to either limb
  • History of ankle sprains to either limb
  • History of musculoskeletal injury sustained in the 6 months prior to enrollment
  • History of concussion or neurological disorders that may influence electroencephalography activity
  • Visual or hearing impairments that would limit receiving the appropriate feedback
  • Inability to comprehend and repeat back directions in English
  • Current smoker

Sites / Locations

  • UNC CharlotteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Internal focus of attention feedback

Visual external focus of attention feedback

Auditory external focus of attention feedback

Arm Description

Participants will complete 12 sessions over 3 weeks receiving visual feedback in a mirror of their movement patterns.

Participants will complete 12 sessions over 3 weeks receiving visual feedback of their movement patterns from a laser.

Participants will complete 12 sessions over 3 weeks receiving auditory feedback of their movement patterns.

Outcomes

Primary Outcome Measures

Changes from baseline in lower extremity biomechanics during landing.
Hip and knee angles and loads measured via 3D biomechanics
Differences in biomechanical changes between visual and auditory external focus of attention feedback.
Hip and knee angles and loads measured via 3D biomechanics

Secondary Outcome Measures

Changes from baseline in cortical activity during landing
Electroencephalography recording of cortical activity during landing

Full Information

First Posted
June 3, 2021
Last Updated
November 4, 2022
Sponsor
University of North Carolina, Charlotte
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1. Study Identification

Unique Protocol Identification Number
NCT04914689
Brief Title
External Focus of Attention Feedback to Reduce Risk of Non-contact ACL Injury
Official Title
External Focus of Attention Feedback to Reduce Risk of Non-contact ACL Injury
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Charlotte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Knee injuries, especially those to the ACL, are common among physically active people. Preventing these injuries from happening is critical to limiting the long-term pain, disability, and arthritis associated with these injuries. Our study is going to examine new ways to provide feedback about the way people move to determine if these are better at modifying movement patterns to prevent injury than current standard treatments. If you participate, you will be asked to undergo a movement analysis in a research laboratory while you perform tasks such as landing from a box and running and cutting. After this initial assessment, you will be randomly allocated to one of 3 treatment groups. Each treatment group will perform 4 weeks (3x/week) of exercises to change the way people land from a jump. Participants will then report for follow-up movement analysis testing 1- and 4-weeks after completing the intervention.
Detailed Description
Despite the popularity of injury prevention programs, anterior cruciate ligament (ACL) injuries continue to occur at a rate of 250,000 per year in the United States. It is believed that 75% of these injuries are preventable, thus alternative strategies to reduce the risk of injury are necessary. One reason current prevention strategies are not wholly successful may be their reliance on internal focus of attention (InFOCUS) feedback, which constrains movement and increases injury risk. Our project will examine an alternative approach, testing two different modes of external focus of attention (ExFOCUS) feedback to remove constrains on the way people move to reduce injury risk. We will also examine cortical activity to determine if there are differences in neuroplasticity that occur following each form of feedback to better understand how each works. Collectively, the knowledge gained from this study will inform the development of programs to reduce injury risk. Specific Aim 1: Determine ExFOCUS's ability to reduce the risk of noncontact ACL injury by retaining improved biomechanics compared to InFOCUS. Hypothesis 1.1: the combined auditory and visual ExFOCUS groups will demonstrate greater improvements in biomechanics and will retain these improvements 1 month after cessation of the intervention. Specific Aim 2: Determine differences in the ability of the two modes (visual and auditory) of ExFOCUS to change biomechanics. Hypothesis 2.1: Auditory ExFOCUS feedback will elicit superior results compared to visual ExFOCUS feedback immediately following the intervention. Specific Aim 3: To quantify differences in cortical activity following external focus of attention and internal focus of attention feedback. Hypothesis 3.1: External focus of attention feedback will increase cortical activity in both groups while there will be no changes in cortical activity during internal focus of attention feedback Hypothesis 3.2: Auditory feedback will elicit greater changes in auditory regions of the brain, while visual feedback will elicit greater changes in regions of the brain responsible for processing visual information.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Internal focus of attention feedback
Arm Type
Active Comparator
Arm Description
Participants will complete 12 sessions over 3 weeks receiving visual feedback in a mirror of their movement patterns.
Arm Title
Visual external focus of attention feedback
Arm Type
Experimental
Arm Description
Participants will complete 12 sessions over 3 weeks receiving visual feedback of their movement patterns from a laser.
Arm Title
Auditory external focus of attention feedback
Arm Type
Experimental
Arm Description
Participants will complete 12 sessions over 3 weeks receiving auditory feedback of their movement patterns.
Intervention Type
Other
Intervention Name(s)
Internal focus of attention feedback
Intervention Description
Participants will complete 12 sessions over a 3-week period of functional movement retraining while receiving mirror feedback. Participants will be instructed to perform each functional task in a manner that keeps their knee in line with their toes.
Intervention Type
Other
Intervention Name(s)
Visual internal focus of attention feedback
Intervention Description
Participants will complete 12 sessions over a 3-week period of functional movement retraining while receiving visual feedback via laser. Participants will be instructed to perform each functional task in a manner that does causes the laser to move up and down but not side-to-side.
Intervention Type
Other
Intervention Name(s)
Auditory external focus of attention feedback
Intervention Description
Participants will complete 12 sessions over a 3-week period of functional movement retraining while receiving auditory feedback. Participants will be instructed to perform each functional task in a manner that does not cause the auditory tool to elicit a noise.
Primary Outcome Measure Information:
Title
Changes from baseline in lower extremity biomechanics during landing.
Description
Hip and knee angles and loads measured via 3D biomechanics
Time Frame
1-week post-intervention, 4-weeks post-intervention
Title
Differences in biomechanical changes between visual and auditory external focus of attention feedback.
Description
Hip and knee angles and loads measured via 3D biomechanics
Time Frame
1-week post-intervention, 4-weeks post-intervention
Secondary Outcome Measure Information:
Title
Changes from baseline in cortical activity during landing
Description
Electroencephalography recording of cortical activity during landing
Time Frame
1-week post-intervention, 4-weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: exercise 30+ minutes 3+ days/week Exclusion Criteria: Body mass index >40 kg/m2 History of lower extremity fracture or surgery to either limb History of ACL tear, meniscus, or collateral ligament injury at the knee to either limb History of ankle sprains to either limb History of musculoskeletal injury sustained in the 6 months prior to enrollment History of concussion or neurological disorders that may influence electroencephalography activity Visual or hearing impairments that would limit receiving the appropriate feedback Inability to comprehend and repeat back directions in English Current smoker
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abbey Thomas, PhD
Phone
704+687+8628
Email
afenwick@uncc.edu
Facility Information:
Facility Name
UNC Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28223
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abbey Thomas, PhD
Phone
704-687-8628
Email
afenwick@uncc.edu
First Name & Middle Initial & Last Name & Degree
Sean Krysak

12. IPD Sharing Statement

Plan to Share IPD
No

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External Focus of Attention Feedback to Reduce Risk of Non-contact ACL Injury

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